Avon Lake, Ohio – PolyOne has recently introduced a medical-grade thermoplastic elastomer (TPE) as an alternative to silicone materials in medical tubing.
Developed particularly for biopharmaceutical tubing applications, the Versaflex HC BT218.TPE is said to offer high levels of weldability, kink-resistance and tensile-strength.
The performance is comparable to leading medical tubing materials, including silicone and other TPEs, PolyOne said in a press statement.
The US compounder said it formulated the new TPE grade in response to silicone shortages and other supply-chain disruptions in the US.
Throughout 2019, the FDA issued multiple alerts regarding medical tubing and potential medical device shortages due to reduced supplies of siloxane, a key ingredient in silicone.
In addition, noted PolyOne, last year saw the closure of multiple ethylene oxide (EtO) sterilisation facilities, leading to higher prices and longer lead-times for end-users.
Polymers for the healthcare industry must generally meet tough regulatory requirements and be suitable for various sterilisation methods, such as gamma-ray and autoclave.